Intraoperative Stereovision for Surgical Guidance

术中立体视觉用于手术指导

• 批准号: 10482607
• 负责人: DAVID W ROBERTS
• 金额: $ 91.47万
• 依托单位: INSIGHT SURGICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482607
• 关键词: 3-Dimensional; Algorithms; Animals; Automation; Brain; Brain Neoplasms; Calibration; Clinical; Code; Computer software; Data; Data Collection; Diagnosis; Entrepreneurship; Excision; Family suidae; Flowcharts; Foundations; Funding; Future; Glioma; Image; Image-Guided Surgery; Incentives; Intellectual Property; Laboratories; Legal patent; Magnetic Resonance Imaging; Malignant neoplasm of brain; Meta-Analysis; Modeling; Multi-site clinical study; Navigation System; Operative Surgical Procedures; Patient-Focused Outcomes; Patients; Performance; Phase; Policies; Procedures; Progress Reports; Progression-Free Survivals; Research; Resected; Risk; Scanning; Site; Software Validation; Speed; Surface; Surgeon; Surveys; System; Technology; Testing; Time; United States National Institutes of Health; Update; Validation; animal data; base; brain tumor resection; career; clinical research site; clinically relevant; commercialization; data acquisition; design; image guided; improved; in vivo; innovation; insight; member; mortality; neurosurgery; pre-clinical; prospective; reconstruction; software systems; verification and validation

PROJECT SUMMARY/ABSTRACT: InSight Surgical Technologies, LLC, is a start-up founded by senior members of a long-standing NIH-funded research effort to develop intraoperative image updating that maintains accurate image correspondence with the surgical field throughout a procedure. The effort has led to research innovations that have generated an intellectual property (IP) portfolio of 13 issued and 8 pending patents. Phase I demonstrated feasibility of new algorithms for assembling multiple intraoperative stereovision (iSV) acquisitions into a composite field-of-view and accomplishing iSV-to-MRI registration/re-registration, and conversion of existing iSV algorithms for 3D surface reconstruction and calibration in graphics processing unit (GPU) accelerated forms. Additionally, Phase I results obtained during resection of a large animal (swine) brain tumor indicate this model is a superb system for testing and validating InSight’s complete image updating system, I2UpdateTM, in vivo in Phase II. Specifically, we will leverage Phase I results to automate I2UpdateTM fully, and demonstrate its technical performance and clinical functionality under quality systems sufficient to meet regulatory requirements. Specific aims will (i) develop a fully-automated, GPU-enabled processing system for intraoperative image-updating (I2UpdateTM), (ii) complete verification testing and pre-clinical in vivo validation of I2UpdateTM, under quality system controls sufficient for supporting regulatory filings at the end of Phase II, and (iii) conduct a multi-site clinical-use study with I2UpdateTM under non-significant risk in patients undergoing brain tumor resection. Successful completion of Phase II will produce the I2UpdateTM product platform as a finalized commercial GPU-enabled software system with concomitant design control, software validation, procedural use and quality systems, accompanied by in vivo animal validation and multi-site, multi-surgeon use demonstrating clinically- relevant and acceptable image-updating performance in terms of automation, computational efficiency and registration accuracy.

项目摘要/摘要： InSight Surgical Technologies, LLC 是一家初创公司，由 NIH 资助的一家历史悠久的公司的高级成员创立 研究工作开发术中图像更新，以保持准确的图像对应 这项努力带来了研究创新，并产生了巨大的影响。 知识产权 (IP) 组合包括 13 项已发布专利和 8 项正在申请中的专利，第一阶段证明了新专利的可行性。 用于将多个术中立体视觉 (iSV) 采集组合成复合视场的算法 并完成 iSV 到 MRI 的配准/重新配准，以及现有 iSV 算法的 3D 转换 图形处理单元 (GPU) 加速形式的表面重建和校准。 在切除大型动物（猪）脑肿瘤期间获得的第一阶段结果表明该模型是一个极好的模型 用于在 II 期体内测试和验证 InSight 完整图像更新系统 I2UpdateTM 的系统。 具体来说，我们将利用第一阶段的结果来完全自动化 I2UpdateTM，并展示其技术 质量体系下的性能和临床功能足以满足特定的监管要求。 目标将 (i) 开发一种全自动、支持 GPU 的处理系统，用于术中图像更新 (I2UpdateTM), (ii) 完成 I2UpdateTM 的验证测试和临床前体内验证，质量保证 系统控制足以支持第二阶段结束时的监管备案，以及 (iii) 进行多站点 在接受脑肿瘤切除术的患者中进行的 I2UpdateTM 临床使用研究，风险不显着。 第二阶段的成功完成将产生 I2UpdateTM 产品平台作为最终的商业产品 支持 GPU 的软件系统，具有伴随的设计控制、软件验证、程序使用和质量 系统，并伴有体内动物验证和多位点、多位外科医生的使用，证明了临床- 在自动化、计算效率和 注册准确性。